Kornimate/medical-research-clean huggingface dataset:
the evaluation of chenopodium formosanum and fagopyrum esculentum extract on anti-aging effect

Conditions: Skin Condition

Summary: to assess chenopodium formosanum and fagopyrum esculentum extract on skin anti-aging


Eligibility criteria:
inclusion criteria: * healthy adults aged between 20-65 years old * subjects must read and sign the informed consent form after the study has been fully explained. * subjects are willing to cooperate and comply with all of the regulation during the trial. * subject should inform to investigator immediately if adverse effect is happened. * subjects are willing to avoid uv overexposure during the trial (include indoor tanning treatment). exclusion criteria: * subjects who have known cosmetic, drug or food allergies. * subjects who have severe desquamation, tattoo, sunburn, peeling skin or other skin condition might impact measurement. * subjects with any physical condition judged by the researcher not to be eligible for this study. * subjects with uncontrollable physical condition such as high blood pressure, thyroid disease, diabetes, etc. * female who is pregnant or nursing or planning to become pregnant during the course of the study. * those who are currently participating in other clinical trials or who have just concluded a clinical trial two weeks ago. * women who have started contraceptive or change current hormone contraceptive methods within 3 months.
a multicenter prospective observational study on vertebral fracture risk stratification in patients with vertebral metastases

Conditions: Vertebral Metastases; Vertebral Fracture

Summary: vertebral fracture is a common clinically significant skeletal related event in cancer patients. stratification of patients diagnosed with one or more vertebral metastases according to the risk of pathological fracture is an unresolved problem despite the fact that fractures strongly influence the quality of life (qol) and also the overall survival. the multidimensional nature and the strong patient specificity of the risk for fracture have not been considered in previously published risk estimation models and these methods were developed and validated only on retrospective data focusing on prevalence of life-time fracture which is not really relevant at the time of the diagnosis of a vertebral metastasis. to overcome these shortcomings, the metastra models (metastra-ai and metastra-vph) and the decision support system (metastra-dss) are developed considering the highest possible level of patient specificity to stratify the individuals according to their risk for fracture in a clinically considerable period (within next 6 months). the prospective data collection and analysis will provide reliability and validity results on the performance of metastra tools as well as structured information on user's experience helping the future integration of the developed patient-specific stratification tool into the everyday clinical practice. the study is a prospective clinical data collection from minimum 200 patients to determine the validity (i.e. precision) in fracture risk stratification of the metastra-ai and metastra-vph computational models and to determine the reliability of metastra-ai and metastra-vph as well as human decision making process in patient stratification.


Eligibility criteria:
inclusion criteria: * patient 18 years or older * patient diagnosed with a metastatic tumor in the thoracic and/or lumbar spine (one or more vertebral metastases in the spinal region between t1 and l5 vertebrae) * min. 1 vertebra is potentially unstable based on sins score (sins is 7-12) and it has not been surgically stabilized previously (level of interest - loi) * adjacent vertebrae are not surgically stabilized at the time of the enrollment * patient willing to complete 6-month follow-up * patient is willing and able to provide written informed consent after the nature of the study has been explained: * ability to understand the content of the patient information/ icf * willingness and ability to participate in the study according to the protocol * signed and dated ec approved written informed consent exclusion criteria: * poor general status at baseline (karnofsky scale less than 40%) * expected life expectancy is less than 3 months at baseline * spinal infection * ongoing litigation * participation in investigational clinical study at the same time or within 3 months * vertebral lesion/metastasis from a hematologic condition (e.g. multiple myeloma)

Keywords: vertebral metastasis cancer fracture risk stratification
a comparison of 2-octyl cyanoacrylate skin adhesive and polyester mesh for wound closure in total knee arthroplasty, a randomized controlled study

Conditions: OsteoArthritis Knee

Summary: the goal of this randomized controlled study is to investigate the efficacy of using skin adhesive (dermabond) and skin adhesive with polyester mesh (dermabond prineo )for wound closure in total knee arthroplasty, the main question it aim to answer 1 are skin adhesive alone and with polyester mesh in total knee arthroplasty different in patient satisfaction evaluated by posas score

nowadays, there are many methods of wound closure in total knee arthroplasty, such as nylon, skin staple, and sterile strip, which differ in advantages and disadvantages of each technique. however, these methods have the same disadvantages: wound discharge, which may lead to infection, wound separation, and the need for wound dressing. it is also a burden for patients and caregivers. in travelling to change the wound in a hospital, there are many costs in terms of wound dressing equipment, travel costs and time off from work for caregivers to take patients to get wound dressing. skin adhesive is an innovation for wound closure in total knee arthroplasty. it reduces the problem of wound separation, with no need for wound dressing. skin adhesive mesh has been studied in many studies, showing that it can be used well. strong it is no different from traditional wound closure; the scar is more beautiful. patients are more satisfied. but the disadvantage is the high price. skin adhesive without polyester mesh has the advantage of being cheaper three times than polyester mesh but less intense than with mesh. this makes it unpopular. no studies have been found comparing wound dressings with mesh and no mesh after knee replacement surgery. therefore, this study is to compare skin adhesive and skin adhesive plus polyester mesh in closure wound total knee arthroplasty. are there differences in patient satisfaction are wound complications such as wound oozing, wound separation, superficial wound skin infection, and contact dermatitis different?

Eligibility criteria:
inclusion criteria: * oa knee need for total knee arthroplasty * age 50-80 years old exclusion criteria: * previous surgery of knee * history of keloid, scar, psoriasis at the knee * history of contact dermatitis with skin adhesive * cognitive impairment

Keywords: dermabond dermabond prineo
clinical evaluation of efficacy and stability of at torbi 709m 4-haptic toric iol in cataract surgery

Conditions: Iol; Astigmatism

Summary: the purpose of this study is to evaluate the efficacy and stability of at torbi 709m 4-haptic toric iol in cataract surgery.

inclusion criteria 1. senile cataract 2. patients' age of 21 years or older 3. preoperative regular corneal astigmatism between 1.00 d and 6.00 d exclusion criteria 1. pregnant, lactating women 2. presence of other ocular diseases which affect stability of lens capsule primary outcome : efficacy index (visual acuity, refractive results secondary outcome : rotational stability, endothelial cell count, cornea thickness

Eligibility criteria:
inclusion criteria: * senile cataract * patients' age of 21 years or older * preoperative regular corneal astigmatism between 1.00 d and 6.00 d exclusion criteria: * pregnant, lactating women * presence of other ocular diseases which affect stability of lens capsule

Keywords: astigmatism toric intraocular lens
a study on safety, pharmacokinetics and pharmacodynamics of lixisenatide in pediatric patients with type 2 diabetes mellitus (t2dm)

Conditions: Type 2 Diabetes Mellitus

Summary: primary objective: to demonstrate safety of 14-day repeated lixisenatide doses with 3 ascending doses as compared to placebo in pediatric patients with t2dm. secondary objectives: * to evaluate plasma concentrations of lixisenatide after repeated doses (3 ascending doses) and pharmacokinetic parameters of repeated lixisenatide doses in pediatric patients with t2dm. * to evaluate the change from baseline in fasting and post-prandial plasma glucose concentrations during a standardized meal test after 3 ascending repeated doses of lixisenatide in comparison to placebo.

the total study duration will be up to 10 weeks that includes a 6-week treatment period with dose escalation every 2 weeks.

Eligibility criteria:
inclusion criteria : * male or female patients aged ≥10 and \<18 years old (at least 4 patients below 16 years old). * body mass index (bmi) \>85th percentile for age and gender; bmi ≤50 kg/m2. * male and female patients with documented t2dm insufficiently controlled with metformin at a stable dose and regimen for 8 weeks prior to randomization and/or basal insulin at stable dose (± 20%) and regimen for 8 weeks prior to randomization. the exact individual metformin dose will be selected according to local regulation and to the investigator's medical judgment. * glycated hemoglobin (hba1c) \>6.5% and ≤11% at screening. exclusion criteria: * if female, ongoing pregnancy (defined as positive serum pregnancy test), breast-feeding. * sexually active postmenarchal female patient who does not agree to use an adequate and highly effective method of contraception throughout the study duration and according to local regulation (ie, hormonal contraception, condom, etc.). * diabetes other than t2dm. * fasting plasma glucose \>250 mg/dl (\>13.9 mmol/l) at screening. * use of other oral or injectable antidiabetic or hypoglycemic agents other than metformin and basal insulin (eg, alpha glucosidase inhibitor, glucagon-like peptide (glp-1) receptor agonist, dipeptidyl peptidase-iv (dpp-iv) inhibitors, short-acting insulin etc.) within 1 month prior to the screening visit. * history of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
the effectiveness of progressive relaxation exercises

Conditions: Functional Outcomes; Muscle Strength

Summary: the purpose of this study is to investigate the effectiveness of progressive muscle relaxation (pmr) exercise on pain, functional outcomes and muscle strength in patients with tka. seventy patients with tka are going to randomly assigned to intervention group and control group.

total knee arthroplasty (tka) is applied in end-stage osteoarthritis to reduce pain, improve functional ability, and provide greater health related quality of life. however, evidence showed that presence of severe pain, impaired functional outcomes and reduced muscle strength continue up to 6 to 12 month after surgery. relaxation techniques such as progressive muscle relaxation exercise and rhythmic breathing have long been used in treating postoperative pain and for various health-related purposes. although the number of studies that include relaxation techniques in treating postoperative pain is increasing, there isn't any study that investigate the effectiveness of progressive muscle relaxation exercise on pain, functional outcomes and muscle strength in patients with tka. the aim is to investigate the effectiveness of progressive muscle relaxation (pmr) exercise on pain, functional outcomes and muscle strength in patients with tka.

Eligibility criteria:
inclusion criteria: * 30 years older above * preoperative diagnosis have to be knee osteoarthritis * have a primary total knee arthroplasty * able to understand turkish instructions * willing and able to attend study exclusion criteria: * revision total knee arthroplasty * unable to understand verbal and written instructions * having previously orthopaedic or neurological disorder that causes gait disturbance

Keywords: total knee arthroplasty progressive muscle relaxation exercise pain functional outcomes muscle strength
a study to evaluate the duration of lastacaft® in acute allergic conjunctivitis

Conditions: Conjunctivitis, Allergic

Summary: this study will evaluate the duration of action of lastacaft® and pataday™ as compared to artificial tears (placebo) in the prevention of ocular itching associated with allergic conjunctivitis.


Eligibility criteria:
inclusion criteria: * history of eye allergies within the past 24 months * willing to not wear contact lenses at least 72 hours prior to the study start and during the study period exclusion criteria: * current eye infection * eye surgery within 3 months or vision correction surgery within 6 months * any planned surgery during the study or 30 days after the study
a study to evaluate the safety of withholding anticoagulation in patients with subsegmental pe who have a negative serial bilateral lower extremity ultrasound

Conditions: Subsegmental (Single or Multiple) Pulmonary Embolism

Summary: blood clots in lung arteries (pulmonary embolism) are usually detected using a radiological test called computed tomography (ct scan). as technology advances, the ct scans are able to detect smaller and smaller blood clots. over time, the frequency of blood clots in the pulmonary arteries has increased significantly (ct scan are now detecting very small blood clots that the investigators could not see before). as a result, more and more people are on blood thinners to treat these small blood clots but their true clinical significance is unknown. the management of blood thinners is costly and also utilizes scarce healthcare resources. these blood thinners need to be monitored with frequent blood work. furthermore, every year, approximately 3 percent of patients on blood thinners will have a major bleeding event requiring medical attention. the investigators don't think that treating these small blood clots in the pulmonary arteries detected on ct scan is worth the risk of bleeding from the blood thinners. the main goal of this study is to find out if it is safe to not treat very small blood clots in the pulmonary arteries. the investigators plan to follow 300 patients with small blood clots in their lungs for 90 days. these patients will not be treated with blood thinners but will be followed closely with other non-invasive tests to avoid progression or recurrence of blood clots.


Eligibility criteria:
inclusion criteria: 1. age greater or equal to 18 years old. 2. patients with newly diagnosed isolated sspe\* (any number). * isolated sspe is defined as ctpa demonstrating an intraluminal filling defect in a subsegmental artery with no filling defects visualized at more proximal pulmonary artery levels. exclusion criteria: 1. proximal lower extremity (popliteal vein or above) or upper extremity (subclavian vein or above) dvt. 2. need for long term oral anticoagulant therapy for reasons other than vte. 3. sspe diagnosed in a hospitalized patient (\> 48 hours after hospital admission). 4. requiring oxygen therapy to maintain an o2 saturation over 92% 5. previous history of dvt (proximal or distal) of upper or lower extremities, pe, or unusual site thrombosis (e.g. splanchnic or cerebral vein thrombosis). 6. geographically inaccessible for follow-up 7. active malignancy (defined as other than basal-cell or squamous cell carcinoma of the skin; cancer within the past 6 months; any treatment for cancer in the past 6 months; or recurrent or metastatic cancer) 8. pregnancy 9. have received more than 48 hours of therapeutic anticoagulation. * prophylactic dose allowed if required for separate indication and acceptable by the investigator. 10. unable/refuse to sign informed consent 11. asymptomatic sspe (e.g. sspe is an incidental finding on a ct scan conducted for reasons other than suspected pe)
suprascapular nerve block guided by ultrasound

Conditions: Rotator Cuff Syndrome

Summary: the purpose of this study is to evaluate the effect of suprascapular nerve block guided by ultrasound combined with home exercises compared with placebo. pain intensity, function, pressure pain threshold and goniometry were designed to be assessed in all patients.

the trial is being carried out in the institute of physical medicine and rehabilitation of the university of são paulo since june 2013. the investigators are including patients with clinical diagnosis of supraspinatus tendinitis based on the lateral jobe test. the patients are being randomized in two arms: active (2% 5ml lidocaine for suprascapular nerve block and home exercises) and placebo control (saline solution as the nerve block and home exercises). the randomization is being performed in blocks of 4 and 6. the investigator, the raters, the md who makes the procedure and the patients are blind to treatment. 4 visits are being performed. screening and initial evaluation visit, procedure visit, follow up 1 week after intervention and follow up 12 weeks after intervention. the sample size was estimated to be 54 in each arm.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of supraspinatus tendonitis, based on jobe's lateral test; * pain longer than 1 month prior to screening visit; * bmi between 20 and 30 kg/m²; * vas of 4 or higher in screening visit; * ability to understand the questionaires and instructions for home exercises; * signed informed consent form; exclusion criteria: * history of: 1. shoulder surgery; 2. athletic activities; 3. severe shoulder arthrosis; 4. diagnosis of total rupture of supraspinatus tendon 5. autoimmune disease; 6. fracture of humerus, acromion and clavicle 7. luxation and subluxation of shoulder. 8. diseases that cause spasticity, such as stroke or spinal cord injury; 9. systemic alterations that can lead to peripheral neuropathy; 10. uncontrolled diabetes or thyroidopathy; 11. diagnosis of cervical spinal cord injury that results in motor alterations; 12. allergy or hypersensibility for local or systemic anaesthetics; 13. coagulopathy; 14. fibromyalgia according to the 1990 american school of rheumatology; 15. uncontrolled psychiatric diseases or controlled psychiatric diseases that need more than two medicines; 16. acute of chronic renal failure; 17. pulmonary diseases that presents hypoxemia such as gold iv chronic obstructive pulmonary disease or pulmonary fibrosis. 18. arrhythmia (except isolated supraventricular extrasystoles), coronary failure or functional class 2 or higher heart failure * pregnancy; * use of oral or subcutaneous anticoagulation agent; * patients who fail to comply with the proposed treatment.

Keywords: rotator cuff syndrome supraspinatus tendonitis suprascapular nerve block ultrasound guided supraspinatus
combined effects of kegel exercises and 4-7-8 breathing technique in primary dysmenorrhea

Conditions: Primary Dysmenorrhea

Summary: a randomized clinical trial will be conducted at riphah international university qie campus in lahore, using non-probability convenience sampling with 28 participants. criteria include women aged 14-26, nulliparous, experiencing primary dysmenorrhea, with normal menstrual cycles and the ability to exercise independently. group a will receive kegel exercises and 4-7-8 breathing techniques over 8 weeks, while group b will only receive the breathing technique. assessments will be done on menstrual cycle days, with follow-ups at weeks 4 and 8 using specific scales. data will be analyzed using spss version 27.

this study will be a randomized clinical trial. riphah international university qie campus in lahore will serve as the site of data collecting and intervention services. non-probability convenience sampling will be the method of sampling. the study's sample size will be 28 participants. inclusion criteria for this study will be: women between ages 14-26 years, nulliparous women, with a score greater than 4 in walidd primary dysmenorrhea intensity scales, history of normal menstrual cycles that lasts 3-7 days and ranged from 21- 35 days, ability to perform exercises independently. group a will be given kegel exercises as well as 4-7-8 breathing techniques for a total of 8 weeks with 4 sessions per week. whereas, group b will be given the 4-7-8 breathing technique only. initial assessment will be taken on the 3rd day of menstrual period. follow-up assessment will be taken after week 4 post interventions and final assessment will be done after week 8 post intervention. walidd primary dysmenorrhea intensity scale, pain self-efficacy questionnaire (pesq), and numeric pain rating scale (nprs) will be the data collecting instruments.

Eligibility criteria:
inclusion criteria: * nulliparous women * women with a score greater than 4 on walidd primary dysmenorrhea intensity scale * women having a history of normal menstrual cycles that lasts 3-7 days and range from 21- 35 days. * ability to perform exercises independently exclusion criteria: * women with very mild primary dysmenorrhea * women treated for ovarian cysts or other gynecological issues * women currently taking medication for dysmenorrhea * history of any systemic illness * a history of psychological conditions that could influence the perception of pain and functional activity.

Keywords: kegel exercises breathing exercises relaxation techniques
effects of epi-no device on pelvic floor dysfunctions

Conditions: Pelvic Floor Disorders; Urinary Incontinence; Dyspareunia; Lacerations Perineal

Summary: perineal injury is the most common maternal obstetric complication associated with vaginal delivery. perineal traumas are associated with maternal morbidity, including pain, urinary and fecal incontinence, genital prolapses, dyspareunia, physical and psychological impairment. epi-no is a device with the objective of preparing and training the pelvic floor for normal childbirth, this training allows smooth and slow movement along the perineal structures in the prenatal period, by causing a rapid traumatic laceration during childbirth. the objective of this study is to verify the effect of 10 pelvic stretching rows with epi-no in preventing urinary incontinence and dyspareunia 6 months after delivery. the study group will consist of primiparous, over 18 years of age, between 30 and 32 weeks of gestation, will be evaluated before the intervention and 6 months after delivery. the control group will be evaluated only once, in the sixth month after delivery. the evaluation will consist of: anamnesis, physical examination (vaginal examination and palpation), perineometry, international urinary incontinence questionnaire (iciq-uisf), visual analogue scale for dyspareunia; questionnaire for assessing dyspareunia female sexual function index (fsfi). pregnant women referred for intervention will perform 10 sessions (twice a week for 5 weeks) of perineal preparation with the epi-no device. it is expected at the end of the study to prove the effectiveness of the effect of 10 pelvic lengthening graft with epi-no in relation to the degrees of laceration and episiotomy and, consequently, reduction of urinary incontinence and dyspareunia.


Eligibility criteria:
inclusion criteria: * primiparous * single fetus exclusion criteria: * patients with complaints of urinary incontinence during or before pregnancy * hypertension and gestational diabetes * placenta previa * twin pregnancy * multiparous * patients who had undergone perineal or vaginal surgery * patients who had urinary tract infection, genital herpes or ongoing candidiasis * and any other diagnosis in which pregnancy becomes at risk.

Keywords: epi-no device vaginal birth